A Study of Investigational Agents in Participants With Previously Treated Stage IV Nonsquamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01H/KEYMAKER-U01)
Start Date
5/13/2025
Completion Date
3/12/2032
Summary
Researchers are looking for new ways to treat metastatic nonsquamous non-small cell lung cancer (NSCLC) that has been treated before. Metastatic means the cancer has spread to other parts of the body. Nonsquamous means the cancer did not start in squamous cells, which are flat cells that line the inside of the lungs. Standard treatment (usual treatment) for NSCLC is surgery, then immunotherapy with or without chemotherapy after surgery. Immunotherapy is a treatment that helps the immune system fight cancer. Chemotherapy is a medicine that works to destroy cancer cells or stop them from growing. However, standard treatment may not work or may stop working for some people. Researchers want to know if 2 antibody drug conjugates (ADCs) can help treat metastatic nonsquamous NSCLC that did not respond (get smaller or go away) to treatment. An ADC attaches to specific targets on cancers cells and delivers treatment to destroy those cells. Researchers will compare 2 different ADCs (the study treatments) to chemotherapy in this study. The goals of this study are to learn: * About the safety of the study treatments and if people tolerate them * How many people have the cancer respond to the study treatments
Detailed Description
The master screening protocol is MK-3475-U01 (KEYMAKER-U01) - NCT04165798
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Raludotatug Deruxtecan
Ifinatamab Deruxtecan
Docetetaxel
5-hydroxytryptamine subtype 3 receptor antagonist
Neurokinin-1 receptor antagonist
Corticosteroid
Conditions
Locations
University of Kentucky Chandler Medical Center ( Site 0019)
Lexington, Kentucky 40536-0293
United States
MedStar Franklin Square Medical Center ( Site 0033)
Baltimore, Maryland 21237
United States
AHN Cancer Institute - Allegheny General ( Site 9501)
Pittsburgh, Pennsylvania 15212
United States
Centro de Estudios Clínicos SAGA ( Site 0161)
Santiago, Region M. de Santiago 7500653
Chile
FALP ( Site 0160)
Santiago, Region M. de Santiago 7500921
Chile
Bradfordhill ( Site 0162)
Santiago, Region M. de Santiago 8420383
Chile
Universitaetsklinik Tuebingen ( Site 0192)
Tübingen, Baden-Wurttemberg 72076
Germany
Charite-Universitaetsmedizin Berlin ( Site 0191)
Berlin, 13353
Germany
THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA"-3rd Dept of Internal Medicine and Laboratory, Oncol ( Site 0204)
Athens, Attica 115 27
Greece
European Interbalkan Medical Center ( Site 0205)
Thessaloniki, 570 01
Greece
Bacs-Kiskun Varmegyei Oktatokorhaz ( Site 0063)
Kecskemét, Bács-Kiskun county 6000
Hungary
Petz Aladar Egyetemi Oktato Korhaz ( Site 0062)
Győr, Győr-Moson-Sopron 9024
Hungary
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet ( Site 0061)
Szolnok, Jász-Nagykun-Szolnok 5000
Hungary
Rambam Health Care Campus ( Site 0076)
Haifa, 3109601
Israel
Shaare Zedek Medical Center ( Site 0075)
Jerusalem, 9103102
Israel
Meir Medical Center ( Site 0071)
Kfar Saba, 4428164
Israel
Rabin Medical Center ( Site 0074)
Petah Tikva, 4941492
Israel
Sheba Medical Center ( Site 0070)
Ramat Gan, 5265601
Israel
Sourasky Medical Center ( Site 0077)
Tel Aviv, 6423906
Israel
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0175)
Milan, Lombardy 20133
Italy
Azienda Ospedaliera Universitaria Careggi ( Site 0173)
Florence, 50134
Italy
Ospedale San Raffaele. ( Site 0171)
Milan, 20132
Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 0174)
Roma, 00168
Italy
Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 0153)
Poznan, Greater Poland Voivodeship 60-569
Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 0151)
Warsaw, Masovian Voivodeship 02-781
Poland
Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0150)
Gdansk, Pomeranian Voivodeship 80-214
Poland
Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie ( Site 0152)
Koszalin, West Pomeranian Voivodeship 75-581
Poland
Institut Català d'Oncologia - L'Hospitalet ( Site 0090)
L'Hospitalet de Llobregat, Barcelona 08908
Spain
Hospital Universitario Quiron Madrid ( Site 0091)
Madrid, 28223
Spain
Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 0141)
Adana, 01250
Turkey (Türkiye)
Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 0140)
Ankara, 06230
Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi. ( Site 0142)
Ankara, 06800
Turkey (Türkiye)
I. U. Cerrahpasa Tip Fakultesi ( Site 0144)
Istanbul, 34098
Turkey (Türkiye)
Ege Universitesi Hastanesi ( Site 0143)
Izmir, 35100
Turkey (Türkiye)